DEXMEDETOMIDINE injection, solution, concentrate

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

DEXMEDETOMIDINE HYDROCHLORIDE (UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO)

Доступна з:

Jiangsu Hengrui Medicine Co., Ltd.

ІПН (Міжнародна Ім'я):

DEXMEDETOMIDINE HYDROCHLORIDE

Склад:

DEXMEDETOMIDINE 100 ug in 1 mL

Адміністрація маршрут:

INTRAVENOUS

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Dexmedetomidine Injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine Injection should be administered by continuous infusion not to exceed 24 hours. Dexmedetomidine Injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Dexmedetomidine Injection prior to extubation. Dexmedetomidine Injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. None. Pregnancy Category C There are no adequate and well-controlled studies of dexmedetomidine use in pregnant women. In an in vitro human placenta study, placental transfer of dexmedetomidine occurred. In a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously. Thus, fetal exposure should be expected in human

Огляд продуктів:

Dexmedetomidine Injection, USP Dexmedetomidine Injection, USP, 200 mcg/2 mL (100 mcg/mL) is clear and colorless, and available in 2 mL clear glass vials. The strength is based on the dexmedetomidine base. Vials are intended for single dose only. NDC No. Container Size 57884-3091-1 Vial 2 mL Single Dose Vial Store at 25°C (77°F), excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

DEXMEDETOMIDINE- DEXMEDETOMIDINE INJECTION, SOLUTION, CONCENTRATE
JIANGSU HENGRUI MEDICINE CO., LTD.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXMEDETOMIDINE INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEXMEDETOMIDINE
INJECTION.
DEXMEDETOMIDINE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Dexmedetomidine Injection is a relatively selective alpha
-adrenergic agonist indicated for:
Sedation of initially intubated and mechanically ventilated patients
during treatment in an intensive care setting.
Administer Dexmedetomidine Injection by continuous infusion not to
exceed 24 hours. ( 1.1)
Sedation of non-intubated patients prior to and/or during surgical and
other procedures. ( 1.2)
DOSAGE AND ADMINISTRATION
Individualize and titrate dexmedetomidine injection dosing to desired
clinical effect. ( 2.1)
Administer dexmedetomidine injection using a controlled infusion
device. ( 2.1)
Dilute the 200 mcg/2 mL (100 mcg/mL) vial contents in 0.9% sodium
chloride solution to achieve required
concentration (4 mcg/mL) prior to administration. ( 2.4)
FOR ADULT INTENSIVE CARE UNIT SEDATION: Generally initiate at one
mcg/kg over 10 MINUTES, followed by a maintenance
infusion of 0.2 to 0.7 mcg/kg/ HOUR. ( 2.2)
FOR ADULT PROCEDURAL SEDATION: Generally initiate at one mcg/kg over
10 MINUTES, followed by a maintenance infusion
initiated at 0.6 mcg/kg/ HOUR and titrated to achieve desired clinical
effect with doses ranging from 0.2 to 1 mcg/kg/ HOUR. (
2.2)
ALTERNATIVE DOSES: Recommended for patients over 65 years of age and
awake fiberoptic intubation patients. ( 2.2)
DOSAGE FORMS AND STRENGTHS
Dexmedetomidine Injection, 200 mcg/2 mL (100 mcg/mL) in a glass vial.
To be used after dilution. ( 3)
CONTRAINDICATIONS
None. ( 4)
WARNINGS AND PRECAUTIONS
Monitoring: Continuously monitor patients while receiving
dexmedetomidine. ( 5.1)
Bradycardia and Sinus Arrest: Have occurred in young healthy
volunteers with